Recall: D-0237-2026

Class III - Minor Violations

Class IIIClassification

2025-11-26Initiated

OngoingStatus

SOMERSET THERAPEUTICS LLCFirm

Product

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.

Reason

Subpotent product:out of specification assay results observed during long term stability testing.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.